Tramvetol 50 mg tablets for dogs

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Tramadol hydrochloride

Beschikbaar vanaf:

Virbac S.A.

ATC-code:

QN02AX02

INN (Algemene Internationale Benaming):

Tramadol hydrochloride

Dosering:

50 mg/tablet

farmaceutische vorm:

Tablet

Prescription-type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutisch gebied:

tramadol

Autorisatie-status:

Authorised

Autorisatie datum:

2019-08-30

Productkenmerken

Health Products Regulatory Authority
06 September 2019
CRN008QD7
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tramvetol 50 mg tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
ACTIVE SUBSTANCE(S):
​
Tramadol (as hydrochloride)
​
43.9 mg
Equivalent to 50 mg of tramadol hydrochloride
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets
White to almost white tablets with brown dots with a break line on one
side, flat, with rounded edges and a characteristic smell
of meat.
Tablets can be divided into 2 equal parts.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs weighing more than 6.25 kg.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the reduction of acute and chronic mild soft tissue and
musculoskeletal pain.
4.3 CONTRAINDICATIONS
Do not administer in conjunction with tricyclic antidepressants,
monoamine oxidase inhibitors and serotonin reuptake
inhibitors.
Do not use in cases of hypersensitivity to tramadol or to any of the
excipients.
Do not use in animals with epilepsy.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The analgesic effects of tramadol hydrochloride may be variable. This
is thought to be due to individual differences in the
metabolism of the drug to the primary active metabolite
O-desmethyltramadol. In some dogs (non-responders) this may result
in the product failing to provide analgesia. For chronic pain,
multimodal analgesia should be considered. Dogs should be
monitored regularly by a veterinarian to ensure adequate pain relief.
In case of recurrence of pain or insufficient analgesia the
analgesic protocol may need to be reconsidered.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Use with caution in dogs with renal or hepatic impairment. In dogs
with hepatic impairment the metabolism of tramadol to the
active metabolites may be decreased which may reduce the efficacy of
the product. One of the active metabolites of tramadol
is renally excreted